MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDAP-05-02-L

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body Embolism (4439)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2021, a 5/2 amplatzer piccolo occluder was selected for implant in a (b)(6) month old, (b)(6) kg patient with the following patent ductus arteriosus(pda) dimensions: aortic end 6.6mm, pulmonary artery end of 4.3mm with the narrowest portion measuring at 3.3mm and a length of 9.5mm.The device was placed intraductal in an acceptable position and released.The device then migrated to the right pulmonary artery(rpa).The device was snared without incident and there was no patient injuries.Multiple other devices were attempted (6mm amplatzer vascular plug ii, 8mm amplatzer vascular plug ii and mvp &q) but none were released from the delivery cable and none were implanted in the patient.There was no clinically significant delay to the procedure.The procedure was aborted, the patient is currently recovering and is scheduled for surgical closure.

Manufacturer Narrative

An event of device embolism was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on the device embolization, per internal procedures.Please note per the instruction for use, arten600042307 version b, sizing chart t2, the recommended size devices for patients >2kg have a maximum duct length of 8mm, and therefore the 9.5mm pda of the reported event falls outside recommended sizing.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11691082
• MDR Text Key: 246224295
• Report Number: 2135147-2021-00153
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7300103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO
• Patient Weight: 4